Instruments currently used in surgical procedures, and in particular arthroplasty procedures such as knee replacement procedures, are typically made out of metal and are reusable. In addition, implant trials are also often reusable and formed of metal or plastic. In a typical knee replacement surgery, there are a large number (up to 8-10) trays filled with hundreds of instruments and trials. After a surgery, each of these individual devices must be cleaned, maintained (i.e., sharpened, checked for damage, etc.), sterilized, and tracked. The instruments and associated logistics relating to cleaning, maintenance, storage and tracking of these instruments are costly, and impose a major burden on the hospital. In addition, if cleaning and sterilization are not performed perfectly, hospital-acquired infections can occur. By utilizing new designs and consolidating parts—made possible through the use of advanced plastic materials and injection molding processes—it has been possible to reduce the number of instruments and the total number of trays to approximately 2-6. This has drastically reduced the reprocessing, sterilization, storage and tracking requirements for these instruments.
For knee replacement surgery, cutting guides are used to remove bone and allow a good fit with the artificial joint implant components. Cutting guides provide for alignment and fit of the joint and are important to good surgical outcomes (i.e., minimizing pain, improving ease of walking, reducing the need for subsequent procedures, etc.). Standard cutting guides, however, are made from metal materials that are designed to be reused and are costly. As a result, they need to be thoroughly cleaned and sterilized. This often requires disassembly and can be problematic due to the many crevices and other areas where biological material can be lodged.
Personalized cutting guides for use in knee arthroplasty procedures have been made from unfilled nylon 12. These cutting guides have less than desired strength and stiffness, however, which can lead to imprecise cuts and wear debris contaminating the surgical site, and which can present an infection hazard. Some personalized cutting guides use metal inserts on cutting surfaces to prevent wear. Metal inserts add significant cost and increase the manufacturing complexity, however.
These and other shortcomings are addressed by aspects of the present disclosure.